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FDA Approves Expanded Use Of Rituxan® For Treatment Of Low-Grade Non-Hodgkin's Lymphoma (NHL)

SOUTH SAN FRANCISCO and SAN DIEGO, CALIF. – May 14, 2001 – Genentech, Inc. (NYSE: DNA) and IDEC Pharmaceuticals Corporation (Nasdaq: IDPH) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biological License Application (sBLA) for Rituxan® (Rituximab).

The new product labeling includes retreatment with Rituxan after a prior course of Rituxan therapy, initial treatment with eight weekly infusions of Rituxan, compared to four infusions, and treatment of bulky disease (tumors greater than 10 centimeters) for patients with relapsed or refractory, low-grade or follicular, CD20 positive B-cell non-Hodgkin's lymphoma (NHL). Additionally, the two companies will emphasize already existing safety information in the revised package insert for physicians concerning rare severe and potentially fatal mucocutaneous skin reactions that have occurred in patients who have received Rituxan.


Rest of the article here:

http://www.gene.com/news/2001/20010514-060424.html

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